MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIVERSAL LIGHT GUIDE ORANGE 5MM X 12 FT; ASSAY, SULFHEMOGLOBIN

Catalog Number 72204925

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 04/29/2020

Event Type  Injury  

Event Description

It was reported that during a knee procedure, the light guide peeled after sterilization for the first time.The procedure was completed with a competitor device.No delay or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device, was returned for evaluation.There was a relationship between the reported event and the device.A visual inspection was performed and showed the orange sheathing on the light guide peeled.The root cause of this failure mode has been identified, as the result of performing the sterrad sterilization process using a sterilization pouch, which can result in damage to the device.The device should be individually wrapped in an approved non-woven polypropylene wrap per the sterrad® instructions for use.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.Instructions for use contains recommendations and precautionary statements for proper use of product.A risk review was performed and showed this failure mode was reported.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: UNIVERSAL LIGHT GUIDE ORANGE 5MM X 12 FT
• Type of Device: ASSAY, SULFHEMOGLOBIN
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10080542
• MDR Text Key: 191791184
• Report Number: 3003604053-2020-00049
• Device Sequence Number: 1
• Product Code: GJC
• UDI-Device Identifier: 00885556643747
• UDI-Public: 885556643747
• Combination Product (y/n): N
• PMA/PMN Number: K914919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72204925
• Device Lot Number: 144378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 06/25/2020
• Supplement Dates FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other